Urine-based diagnostic devices in their generic form are used in home and clinical settings for both men and women to test for a wide variety of conditions and analytes that may be present in urine and other body fluids. The devices have been developed to provide for quick, accurate, and easy-to-use testing for people untrained in the field.
Existing devices typically comprise at least two parts: a rigid structure to serve as a support for the device, and a testing strip which carries out the test itself. Such devices use rigid body structures, an imprecise specimen collection method (sometimes requiring counting from the user), singular abstract readout per testing strip (in non-electronic devices), and implied landfill disposal. Urine-based diagnostics usually fall into the categories of midstream (device is held in flowing stream of fluid), dip (device is held in stationary fluid sample), and cassette (dropper is used to add fluid sample).
The increasing popularity and complexity of these devices have led to a number of problems. Those of skill in the art will appreciate that a test format remains desirable that integrates the entirety of the device, including the user interface, collection portion, and testing portion, into a single format. This would help to simplify the manufacturing process as well as to improving the ease-of-use of the device. Additionally, the increase in complexity of existing devices has enabled such devices to give electronic readouts of the results at the expense of increasing cost and the requirement of battery operation. Those of skill in the art would appreciate a testing format in which the device is able to give both a positive and negative indicator without the use of electronic components remains desirable. This solution would be particularly important as it aids the user experience, reduces cost, simplifies manufacture, and avoids the use of expensive, and non-biodegradable electronic components. The user experience could be even further improved by using a visual readout that has a clearer indication than the current non-electronic devices in the market that typically use one or more lines to indicate the result which are often difficult to interpret.
Because these diagnostic devices are often used to obtain sensitive test results, discretion is typically an important priority for the user. There are a number ways to improve test discretion. For discretion while carrying the device, it would be desirable to create a device that is not only small, but is able to be folded to compact form without damaging the device itself. Additionally, discretion at disposal can be particularly important where one would not want the device to be found. Therefore, a test format that is completely flushable or water dispersible would be advantageous. A flushable, water dispersible, or biodegradable device would also be desirable as it would reduce dependency on landfill systems.
Ease-of-use is also important for these types of at-home testing devices which are typically used by untrained people. Typical hand-held devices are rigid and require aiming of urine on the part of the user, which tends to be particularly difficult for females. Other devices in the field attempt to solve this problem by allowing the user to dip the test in a sample, or attach the device to a toilet. Those of skill in the art would recognize that a device that could aid in sample collection and testing without first collection of the sample in a separate container, or attaching the device to an object for collection, would be advantageous to ease the user experience.